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Executive Summary

UPJOHN'S ROGAINE IS "APPROVABLE" FOR MALE PATTERN BALDNESS: the firm's topical 2% minoxidil formulation reached the next-to-last approval stage on Aug. 9. The NDA for Rogaine, which was filed in December 1985, has been reviewed by two FDA review groups, the Dermatology and Cardio-Renal Divisions. The antibaldness preparation has been approved in 45 countries to date. Upjohn has been predicting the imminent approval of Rogaine since 1987. However, a Canadian study published early this year presented evidence that the antihypertensive drug could be systemically absorbed through topical use. Agency review of those findings may have been one source of approval delay. Upjohn plans to begin marketing Rogaine within one month of final approval. The firm has also said that promotion will include an emphasis on the consumer, with direct-to-consumer advertising a possibility. At a December analyst meeting, Upjohn President Lawrence Hoff called Rogaine "an OTC product in prescription clothing," noting that "its market, like an OTC product's, is consumer driven." One interesting political/policy sidelight to watch following the final approval for Rogaine will be the reaction of House Energy & Commerce Committee Chairman Dingell. The Michigan Democrat has been an adamant foe of direct-to-consumer advertising. However, he has also been supportive of Upjohn (a home-state company) in the past. He recently, for example, initiated an inquiry into OTC drug approval practices based on concern about OTC hair growth products ("The Pink Sheet" July 11, p. 6). Upjohn could skirt the issue by keeping its baldness message very general. As long as it holds an exclusive position, the company will not be pressed to test the boundaries of direct-to-consumer ads. A "talk to your doctor" consumer advertising campaign that broke in Canada earlier in the year is a likely model for U.S. promotions ("The Pink Sheet" Dec. 21, 1987, p. 8). That campaign, which has included print and TV ads, has mentioned neither the product nor the company, but has recommended that hair loss sufferers consult physicians for information on "new treatment programs" for baldness. Upjohn said it is "pleased" with the way Rogaine sales in Canada have responded to consumer promotions. The firm had attributed initially slower sales to the fact that there was a two or three-month lag time between initial availability of the drug and the start of direct-to-consumer advertising. Whether heavily advertised or not, Rogaine is likely to be the beneficiary of wide media coverage. The product is discussed at length in the cover article of the most recent Consumer Reports magazine.

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